Mild Cognitive Impairment (MCI)MEDIPHENO-HTNCT07672938
Effects of Hydroxytyrosol-Rich Olive Polyphenol Dietary Supplement Combined With Mediterranean Diet Adherence on the Cognitive Health of Patients With Mild Cognitive Impairment
A study testing Low-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement and High-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement in people with Mild Cognitive Impairment (MCI), run by Panhellenic Federation of Alzheimer's Disease and Related Disorders at 1 site in Greece.
Trial summary
Nutrition is an important modifiable risk factor of human cognitive health. Increasing data suggests that certain nutrients or food ingredients, such as plant polyphenols, have the potential to benefit cognitive abilities even in later life. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Low-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement and High-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteGreece
- Study dates
- 31 Mar 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GR-based men and women aged 50 - 85
- Willingness and ability to conform to the full protocol.
- Ability to accept and sign the consent form.
- Presence of a diagnostic classification of Mild Cognitive Impairment according to the National Institute on Aging and Alzheimer's Association (NIA-AA) framework MCI, which corresponds to stage 3 on the pre-dementia range.
- MoCA score of ≥18 and ≤ 26. Or
- MMSE (Mini-Mental State Examination) score of ≥26 and ≤ 28.
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- No active suicide ideation based on the Columbia-Suicide Severity Rating Scale.
- Absence of severe depressive symptomatology based on the Geriatric Depression Scale-15.
- Not using any laxative drugs for at least three days prior to the screening visit.
- Information about APOE status
Who cannot join
- Patients with mild, moderate, or severe dementia.
- Current or recent (within the last 4 weeks) engagement with a strict dietary regime i.e., vegetarian / vegan / ketogenic / paleolithic / high protein / weight loss.
- Any known issues with blood taking.
- Any known bleeding disorders.
- Any known allergy to olives, inability to tolerate gluten or multiple allergies/intolerances that would significantly limit food intake.
- Average alcohol use of >21 glasses per week for men and >14 glasses per week for women (on average for the last six months).
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- History of psychiatric illness including intellectual disability, schizophrenia, bipolar disorder, severe, active depression and alcoholism.
- Neurologic conditions such as vascular dementia, movement disorders, history of conditions such as anaemia and cancer in the last five years, renal or liver failure, malignant tumours, or organ transplant.
- Coffee consumption greater than 5 cups per day.
- Body mass index > 35 kg/ m2.
- Not taking a stable dose of statins for at least 3 months before the recruitment visit. Taking antibiotics in the 1 week preceding the recruitment visit.
- Pregnancy or lactation.
- Participation in another clinical trial during the last 30 days prior to the recruitment visit.
- Subject taking supplements that may affect lipoprotein metabolism, >1 g of fish oil/day, antioxidant supplements, cannabidiol (CBD) oil.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Palliative Care Centre "Panagia Glykofilousa", Greek Association of Alzheimer's Disease and Related Disorders, Plastira 65, Thessaloniki 54250, Greece.
Thessaloniki, Central Macedonia, 54250
Magda Tsolaki, Professor Emeritus, MD, PhD, +30 2310316143, tsolakim1@gmail.com
About this study
Official title: Hydroxytyrosol-Rich Olive Juice Polyphenol and Mediterranean Diet (The MEDIPHENO-HTrial) in Prevention of Cognitive Decline in Community-Dwelling Patients With Mild Cognitive Impairment: A Double-Blind, Placebo-Controlled, 3-Arm, Randomised Controlled Clinical Study
Nutrition is an important modifiable risk factor of human cognitive health. Increasing data suggests that certain nutrients or food ingredients, such as plant polyphenols, have the potential to benefit cognitive abilities even in later life. In terms of polyphenols, Hydroxytyrosol (HT) has gained health benefit claims as a potential preventative antioxidant supplementation of neurodegenerative and amyloid-associated diseases while its pharmacological mechanisms suggest protection against cognitive decline. The primary objective of this study will be to evaluate the effects of HT-rich olive juice polyphenol supplementation alongside MeDi adherence compared with placebo alongside MeDi adherence in the prevention of cognitive decline among patients with Mild Cognitive Impairment associated with AD and non-AD pathology.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Low-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement, High-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement, Placebo
- Keywords
- Dementia Prevention, Phenolic-rich Nutritional Intervention, Hydroxytyrosol, Mediterranean Diet, Neurodegenerative Biomarkers, Public Health, Clinical Trial
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol SupplementDietary supplement
This is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial. The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies. Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo. The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding.
High-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol SupplementDietary supplement
This is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial. The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies. Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo. The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding.
PlaceboDietary supplement
This is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial. The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies. Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo. The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding.
| Study group | Role | What they receive |
|---|---|---|
| Active Arm - Low Dose | Active comparator | Low dose: 8 drops (20mg of polyphenols) + Mediterranean Diet instructions Receives: Dietary Supplement: Low-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement |
| Experimental Arm - High Dose | Experimental | High dose: 16 drops (40mg of polyphenols) + Mediterranean Diet instructions Receives: Dietary Supplement: High-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement |
| Placebo Comparator Arm | Placebo comparator | Placebo 8 drops + Mediterranean Diet instructions Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: Mean change on the Alzheimer's Disease (AD) Assessment Scale-Cognitive Subscale (ADAS-Cog) total score from baseline to Week 52 compared with placebo
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the cognitive performance of patients with MCI as measured by ADAS-Cog. ADAS-Cog ranges from 0-85 by summing the number of errors made on each task, so that higher scores indicate worse performance.
Measured: From baseline to Week 52
Secondary outcomes (11)
Key secondary: Mean change on the Montreal Cognitive Assessment Test (MoCA) total score from baseline to Week 52 compared with placebo
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the cognitive performance of patients with MCI as measured by MoCA. The total possible score for the test is 30 points by summing the number of correct responses given in each task, so higher scores indicate better performance.
Measured: From baseline to Week 52
- Mean change on Clinical Dementia Rating - Sum of boxes (CDR-SB) from baseline to Week 52 compared with placebo
- The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the CDR-SB, which ranges from 0 to 18, and is calculated by summing the ratings across each of the six domains (memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care), with higher scores indicating greater impairment.
Measured: From baseline to Week 52
Mean change on Mini-Mental State Examination (MMSE) from baseline to Week 52 compared with placebo
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the MMSE, which is a 30-point brief screening measure of cognitive status. Higher scores indicate better performance.
Measured: From baseline to Week 52
- Mean change on Geriatric Depression Scale-15 (GDS-15) from baseline to Week 52 compared with placebo.
- The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on GDS-15, which consists of 15 items and is used to screen for depression in adults. GDS-15 assess mental health based on feelings over the past week, with higher scores on the measure denoting more severe levels of depressive symptoms.
Measured: From baseline to Week 52
- Mean change on Short Anxiety Screening Test (SAST-10) from baseline to Week 52 compared with placebo
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on SAST-10, which is a brief questionnaire designed to assess anxiety. SAST-10 scores range from 10 to 40, with higher scores on the measure denoting more severe levels of anxiety symptoms.
Measured: From baseline to Week 52
- Mean change on Functional Rating Scale of Symptoms of Dementia (FRSSD) from baseline to Week 52 compared with placebo.
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on FRSSD. The scale ranges from 0 (fully independent) to 42 (fully dependent), with lower scores indicating better daily functioning.
Measured: From baseline to Week 52
- Mean change on Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale for use in Mild Cognitive Impairment (ADCS-MCI-ADL) from baseline to Week 52 compared with placebo.
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on ADCS-MCI-ADL, which is a brief questionnaire designed to capture functional abilities (with recall "In the past 4 weeks"). The 18-item ADCS-ADL-MCI is scored from 0 to 53 based on the subject's degree of independence in performing specific tasks. Lower scores on the measure denote more substantial impairment.
Measured: From baseline to Week 52.
- Mean change on Quality of life in Alzheimer's disease (QoL-AD) from baseline to Week 52 compared with placebo.
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on QoL-AD, which is a brief 13-item questionnaire designed to assess quality of life. QoL-AD range from 13 to 52, with higher scores indicating better quality of life.
Measured: From baseline to Week 52.
- Mean change on - Pittsburgh Sleep Quality Index (PSQI) from baseline to Week 52 compared with placebo.
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on PSQI, which is a questionnaire designed to assess Sleep quality. PSQI range from 0 to 21, with higher scores indicating poor sleep.
Measured: From baseline to Week 52.
- Mean change in LDL-C mg/dL cholesterol from baseline to Week 52 compared with placebo.
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on LDL-C mg/dL cholesterol.
Measured: From baseline to Week 52
- Mean change in HDL-C mg/dL cholesterol from baseline to Week 52 compared with placebo.
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on HDL-C mg/dL cholesterol.
Measured: From baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start31 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Panhellenic Federation of Alzheimer's Disease and Related Disorders
- Sponsor type
- University, hospital or other
- Collaborators
- Palliative Care Centre "Panagia Glykofilousa", Greek Association of Alzheimer's Disease and Related Disorders, Plastira 65, Thessaloniki 542 50, Greece., Levius Vita Foods srl
- Responsible party
- Sponsor
- Investigators
- Vilma Chalili, Principal investigator, School of Medicine, Aristotle University of ThessalonikiMagda Tsolaki, Study chair, First Department of Neurology, Faculty of Health Sciences, School of Medicine, Aristotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672938
- Sponsor's protocol ID
- 107/12-3-2025
- Acronym
- MEDIPHENO-HT
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxytyrosol-Rich Olive Juice Polyphenol and Mediterranean Diet (The MEDIPHENO-HTrial) in Prevention of Cognitive Decline in Community-Dwelling Patients With Mild Cognitive Impairment: A Double-Blind, Placebo-Controlled, 3-Arm, Randomised Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07672938
- Acronym / sponsor ID
- MEDIPHENO-HT / 107/12-3-2025
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Dementia Prevention, Phenolic-rich Nutritional Intervention, Hydroxytyrosol, Mediterranean Diet, Neurodegenerative Biomarkers, Public Health, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Panhellenic Federation of Alzheimer's Disease and Related DisordersUniversity, hospital or other
- Collaborators
- Palliative Care Centre "Panagia Glykofilousa", Greek Association of Alzheimer's Disease and Related Disorders, Plastira 65, Thessaloniki 542 50, Greece., Levius Vita Foods srl
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nutrition is an important modifiable risk factor of human cognitive health. Increasing data suggests that certain nutrients or food ingredients, such as plant polyphenols, have the potential to benefit cognitive abilities even in later life. In terms of polyphenols, Hydroxytyrosol (HT) has gained health benefit claims as a potential preventative antioxidant supplementation of neurodegenerative and amyloid-associated diseases while its pharmacological mechanisms suggest protection against cognitive decline. The primary objective of this study will be to evaluate the effects of HT-rich olive juice polyphenol supplementation alongside MeDi adherence compared with placebo alongside MeDi adherence in the prevention of cognitive decline among patients with Mild Cognitive Impairment associated with AD and non-AD pathology.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Arm - Low Dose | Active comparator | Dietary Supplement: Low-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol SupplementLow dose: 8 drops (20mg of polyphenols) + Mediterranean Diet instructions |
| Experimental Arm - High Dose | Experimental | Dietary Supplement: High-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol SupplementHigh dose: 16 drops (40mg of polyphenols) + Mediterranean Diet instructions |
| Placebo Comparator Arm | Placebo comparator | Dietary Supplement: PlaceboPlacebo 8 drops + Mediterranean Diet instructions |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- GR-based men and women aged 50 - 85
- Willingness and ability to conform to the full protocol.
- Ability to accept and sign the consent form.
- Presence of a diagnostic classification of Mild Cognitive Impairment according to the National Institute on Aging and Alzheimer's Association (NIA-AA) framework MCI, which corresponds to stage 3 on the pre-dementia range.
- MoCA score of ≥18 and ≤ 26. Or
Key exclusion criteria (14 listed)
- Patients with mild, moderate, or severe dementia.
- Current or recent (within the last 4 weeks) engagement with a strict dietary regime i.e., vegetarian / vegan / ketogenic / paleolithic / high protein / weight loss.
- Any known issues with blood taking.
- Any known bleeding disorders.
- Any known allergy to olives, inability to tolerate gluten or multiple allergies/intolerances that would significantly limit food intake.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol SupplementThis is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial. The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies. Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo. The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding. | Dietary supplement | Active Arm - Low Dose |
| High-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol SupplementThis is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial. The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies. Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo. The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding. | Dietary supplement | Experimental Arm - High Dose |
| PlaceboThis is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial. The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies. Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo. The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding. | Dietary supplement | Placebo Comparator Arm |
Primary outcome
Primary: Mean change on the Alzheimer's Disease (AD) Assessment Scale-Cognitive Subscale (ADAS-Cog) total score from baseline to Week 52 compared with placebo
Time frame: From baseline to Week 52
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the cognitive performance of patients with MCI as measured by ADAS-Cog. ADAS-Cog ranges from 0-85 by summing the number of errors made on each task, so that higher scores indicate worse performance.
11 secondary outcomes
Key secondary: Mean change on the Montreal Cognitive Assessment Test (MoCA) total score from baseline to Week 52 compared with placebo
Time frame: From baseline to Week 52
- Mean change on Clinical Dementia Rating - Sum of boxes (CDR-SB) from baseline to Week 52 compared with placebo
Time frame: From baseline to Week 52
Mean change on Mini-Mental State Examination (MMSE) from baseline to Week 52 compared with placebo
Time frame: From baseline to Week 52
- Mean change on Geriatric Depression Scale-15 (GDS-15) from baseline to Week 52 compared with placebo.
Time frame: From baseline to Week 52
- Mean change on Short Anxiety Screening Test (SAST-10) from baseline to Week 52 compared with placebo
Time frame: From baseline to Week 52
- Mean change on Functional Rating Scale of Symptoms of Dementia (FRSSD) from baseline to Week 52 compared with placebo.
Time frame: From baseline to Week 52
- Mean change on Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale for use in Mild Cognitive Impairment (ADCS-MCI-ADL) from baseline to Week 52 compared with placebo.
Time frame: From baseline to Week 52.
- Mean change on Quality of life in Alzheimer's disease (QoL-AD) from baseline to Week 52 compared with placebo.
Time frame: From baseline to Week 52.
- Mean change on - Pittsburgh Sleep Quality Index (PSQI) from baseline to Week 52 compared with placebo.
Time frame: From baseline to Week 52.
- Mean change in LDL-C mg/dL cholesterol from baseline to Week 52 compared with placebo.
Time frame: From baseline to Week 52
- Mean change in HDL-C mg/dL cholesterol from baseline to Week 52 compared with placebo.
Time frame: From baseline to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vilma Chalili principal investigator
School of Medicine, Aristotle University of Thessaloniki
Magda Tsolaki study chair
First Department of Neurology, Faculty of Health Sciences, School of Medicine, Aristotle University of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement and High-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement in people with Mild Cognitive Impairment (MCI), run by Panhellenic Federation of Alzheimer's Disease and Related Disorders at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magda Tsolaki, Professor Emeritus, MD, PhD (+30 2310316143, tsolakim1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary: Mean change on the Alzheimer's Disease (AD) Assessment Scale-Cognitive Subscale (ADAS-Cog) total score from baseline to Week 52 compared with placebo (time frame: From baseline to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.